What Happened In The MassTorts World Last Week? 2019-May-06
Recall of Teva Losartan Tablets Announced by FDA
The FDA has announced recall of Teva Losartan Tablets on April 27, 2019, due to the presence of cancer-causing Nitroso-N-methyl-4-aminobutyric acid (NMBA) in at least six lots of active pharmaceutical ingredient manufactured by Hetero Labs Limited in India.
NMBA has been linked to reports of liver cancer, kidney cancer, gastric cancer and other injuries among users of blood pressure drugs. Similar recalls have been linked to the presence of N-nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), which have the same effect and has impacted generic versions of valsartan, losartan, irbesartan, and other products. The latest losartan recall only applies to the lots with a higher level of NMBA. This recall has affected six lots of Losartan Potassium Tablets, USP 25mg, which are light-green in color, film-coated and teardrop-shaped biconvex tablets. They are embossed with “LK 25” on one side and “>” on the other. This has also affected 29 lots of Losartan Potassium tablets USP 100 mg, which are dark green, film-coated, oval-shaped biconvex tablets which have “LK100” on one side and “>” on the other.
According to the recall, Teva has notified Golden State Medical Supply of Camarillo, California, the need for the recall, and the distributors and retailers are urged to stop selling the pills. A list of affected lots is available in the recall. Also, patients taking these are advised to continue taking them until they find an alternative tablet or treatment as discontinuing these pills would have a more adverse effect. The FDA has requested to report adverse events to MedWatch Adverse Event Reporting Program.
Case Management Conference Held for Talcum Powder Lawsuit
Ahead of the case management conference held on April 29, 2019, the parties involved in the talcum powder litigation submitted a joint report outlining the status of the litigation, along with the agenda for topics to be addressed in the court.
According to the report, there are around 10,556 Talcum powder lawsuits and Shower-to-Shower lawsuits filed in the federal court system along with 2,400 additional cases filed in state courts nationwide. As per the litigation, 10,000 cases have been filed by women in the U.S who allege they developed ovarian cancer, mesothelioma or other injuries due to years of asbestos exposure. The conference agenda includes the status of expert discovery, challenges to the admissibility of certain scientific evidence, pending motions and the growing number of complaints filed in state and federal courts nationwide.
U.S. District MDL Judge Freda L. Wolfson determined that plaintiffs had sufficient evidence to link talcum powder and cancer to proceed to trial under federal rules. It is expected that a small group of “bellwether” cases will be set for trial in the U.S. District Court for the District of New Jersey and large numbers of cases will eventually be remanded back to different federal district courts for individual trial dates in the future.
Sackler Family Aims Global Settlement For Opioid Lawsuits
Purdue Pharma is facing more than 2,000 opioid lawsuits from different states, cities, and counties. Mary Jo White, attorney of Sackler family who owns Purdue Pharma, recently stated litigation against the family and their company was legally unreliable and factually misleading, but still, they are ready for the global opioid settlement.
Arkansas’s Attorney General Leslie Rutledge, filed a lawsuit in the Pulaski Circuit Court against three opioid distributors, AmerisourceBergen Drug Corporation, McKesson Corporation, and Cardinal Health. She stated these distributors control 85 percent of the national opioid market share and collectively make more than $375 billion in annual revenue. Rutledge also filed a lawsuit last year against Purdue Pharma, Johnson & Johnson and Endo Pharmaceuticals for misleading the public on the dangers of opioids. Camden Clark Memorial Hospital Corporation in West Virginia along with 27 others have sued opioid manufacturers, distributors and others on similar lawsuit. Fourteen other states and one U.S. territory are also currently pursuing lawsuits against opioid manufacturers and distributors.
Jury Awards Covil Corp Worker's Family $32.7M
In one of the state’s largest mesothelioma verdicts, a North Carolina jury awarded the estate of an erstwhile worker $32.7 million following a five-day trial in October. Recently, the defendant’s appeal to overturn the verdict was denied.
The worker started working at a Firestone tire facility in Wilson, North Carolina in 1975 and worked there until 1995. During his employment, he worked in the company’s curing room changing tire molds on asbestos-containing platen insulators, gaskets, and other replacement parts. According to Jessica Dean of Dean Omar & Branham LLP, an attorney representing the plaintiffs, the exposure to asbestos-containing insulation supplied by company Covil Corp. was found responsible for damages. The worker was diagnosed with mesothelioma and succumbed to the disease before the trial at the age of 78.
The case is filed in the U.S. District Court for the Middle District of North Carolina.
Roundup's Primary Glyphosate Safe To Use Assures EPA
EPA recently announced over the usage of Glyphosate that it doesn't cause cancer.
According to the review, glyphosate is the most-used herbicide in the U.S and meets the standard in the Federal Insecticide, Fungicide, and Rodenticide Act. It is one of the primary ingredients of Roundup. The California Office of Environmental Health Hazard Assessment had included glyphosate on a list of carcinogenic chemicals based on the World Health Organization’s International Agency for Research(IARC). EPA stated, it probably doesn't cause cancer and can be used with some fine adjustments; also, its testing methods are more superior than IARC's.
The first trial against Monsanto over Roundup was held last summer in state court in San Francisco, which ruled in favor of plaintiffs with $78 million. The second ended last month in federal court with an $80 million verdict, including $75 million in punitive damages. The third trial is ongoing.
3M Earplug Lawyers Summon On “Science & Technology Day”
According to an April 23rd Case Management Order, for all federally-filed 3M Earplug lawsuits, a "Science & Technology Day" has been scheduled for June 18, 2019, to educate the court on the scientific aspect of the litigation. The presentations used in the court will not be used for any other purposes in the litigation.
The day will begin at 9:00 a.m and all parties counsel should submit the agenda to the Court by June 7th. It also indicates that plaintiffs might soon be able to file their 3M Earplugs lawsuits directly in the Northern District of Florida. There are around 600 military veterans who have filed for Combat Arms Earplugs claiming they suffered from design defects which left them unprotected during combat, resulting in permanent hearing loss and/or tinnitus. 3M Company acquired Aearo Technologies Inc. who developed Combat Arms Earplugs, Version 2, knew about these defects but failed to provide any solution or warning. Also, the U.S. Department of Justice had announced a $9.1 million settlement in the case last July, but the company did not compensate and denied the allegations on faulty earplugs.
The reversible earplugs featured a yellow end that blocked damaging impact sounds typically encountered on the battlefield but allowed the user to hear commands and other low-level noises. The earplugs’ green end performed like traditional earplugs and blocked all sounds.
Court Orders Valsartan Defendants To Submit Primary Findings
According to a court order dated April 29, valsartan recall defendants should submit their findings outlined in the order by June 17, 2019. The core discovery will be limited only to valsartan medications and not losartan or irbesartan products. Any recall defendants failing to submit the findings should inform the court about their intention by May 27. A telephonic conference will be held on May 8, at 3:00 p.m., to finalize the terms of a Discovery Confidentiality Order, followed by an in-person conference on May 29 to finalize the parties’ Profile Forms and Short Form Complaints, as well as an Order regarding the parties’ group organization and leadership.
The recall began last year after carcinogenic nitrosamines were discovered in active pharmaceuticals ingredients manufactured by Zhejiang Huahai Pharmaceutical Co. which was due to some alteration in its production methods. Research shows nitrosamines are linked to gastrointestinal tract cancers, including colon cancer, stomach cancer, and esophageal cancer. Also, nitrosamines may cause liver cancer, kidney cancer, and pancreatic cancer. There are 50 valsartan lawsuits pending in the federal litigation underway in New Jersey. The proceeding involves over 40 valsartan recall defendants, including Zhejiang Huahai, Teva Pharmaceutical Industries Ltd., Mylan NV, and CVS Health Co.
McKesson’s $37M West Virginia Opioid Lawsuit Settlement
The West Virginia Attorney General, Patrick Morrisey, announced that McKesson Corp. has agreed to pay $37 million to resolve claims that the company fueled the opioid epidemic. The drug distributor will pay $14.5 million this year followed by five more annual payments of $4.5 million until 2024. This is believed to be one of the biggest settlements against a distributor. The lawsuit was filed in 2016 in a West Virginia circuit court which stated McKesson shipped millions of doses of both oxycodone and hydrocodone between 2007 and 2012 along with large amounts of other narcotics illegally. In 2017, McKesson agreed to pay a $150 million penalty to settle the violations of the Controlled Substances Act.
The recent West Virginia settlement follows the $270 million deal Purdue Pharma struck in March with the state of Oklahoma to exit the opioid lawsuit crisis. There are more than 1,600 cases over the opioid crisis, filed largely by local governments, Native American tribes, and hospitals. The first trial in the MDL No. 2804 is set to start in October 2019.
Bayer Ready To Intervene In Roundup Lawsuit
U.S. District Judge Vince Chhabria stated that Bayer and a plaintiff has been ordered to go into confidential mediation in a Roundup lawsuit. The filing suggests both parties propose and agree on a mediator or else the court will appoint one. The trial scheduled for May 20 is canceled, and a new date will be set; the mediation efforts will be discussed on May 22.
The company plans to defend its glyphosate-based products in court claiming the product to be safe and stands behind the science supporting the product’s safety. In a recent verdict against Bayer, the judge awarded the plaintiff $80 million. Mediation is done confidentially, and the settlements are not released to the public. The mediation resources spent on the trial will be spent on multidistrict litigation under MDL No. 2741.